NCT07109726RecruitingPhase 1
A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
Terremoto Biosciences Inc.27 sites in 4 countries205 target enrollmentStarted: September 23, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 205
- Locations
- 27
- Primary Endpoint
- Objective Response Rate as assessed by RECIST v1.1
Study Overview
Brief Summary
This is a Phase 1/2, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TER-2013 in patients with advanced solid tumors harboring AKT/PI3K/PTEN pathway alterations.
Detailed Description
This is a first-in-human clinical trial that will evaluate the safety, tolerability, and pharmacokinetics (PK) of TER-2013 as a monotherapy and in combination with fulvestrant and to determine the maximum tolerated/administered dose and preliminary clinical activity. The study consists of two parts: Part 1-Dose Escalation and Part 2 -Dose Expansion.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Metastatic or locally advanced, unresectable disease
- •No available treatment with curative intent
- •Presence of lesions to be evaluated per RECIST v1.1:
- •a. Dose Escalation: measurable or evaluable disease b. Cohort Expansion: measurable disease
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate organ function
- •Advanced solid tumor malignancy harboring an eligible AKT/PI3K/PTEN pathway alteration detected by a sponsor approved test
- •Key Inclusion Criteria for TER-2013 monotherapy arms:
- •Histologically confirmed diagnosis of:
- •a. [For TER-2013 dose escalation]: solid tumor malignancy b. [For TER-2013 cohort expansion]: i. Cohort 1: ovarian cancer, cervical cancer, or squamous cell carcinoma of the head and neck, lung, or esophagus ii. Cohort 2: endometrial adenocarcinoma
- •Prior therapy:
- •[For TER-2013 dose escalation]: Received standard therapies appropriate for their tumor type and stage, unless contraindicated, intolerable, or patient refused
- •[For TER-2013 cohort expansion]: No more than 3 prior lines of treatment in the advanced setting
- •Key Inclusion Criteria for TER-2013 and fulvestrant combination arms
- •Histologically confirmed diagnosis of:
- •a. [For TER-2013 + fulvestrant dose escalation]: HR+/HER2- advanced unresectable or metastatic breast cancer b. [For TER-2013 + fulvestrant cohort expansion]: i. Received treatment with an AI containing regimen (single agent or in combination) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting
- •Prior Therapy:
- •a. [For TER-2013 + fulvestrant dose escalation]: Received treatment with an AI containing regimen (single agent or in combination) b. [For TER-2013 + fulvestrant cohort expansion]: i. Received treatment with an AI containing regimen (single agent or in combination) ii. No more than 3 prior lines of treatment in the advanced unresectable or metastatic setting
Exclusion Criteria
- •Known EGFR, KRAS, NRAS, HRAS, or BRAF oncogenic-driver co-mutation with PI3K/AKT/PTEN alteration
- •Clinically significant abnormalities of glucose metabolism
- •Active brain metastases or carcinomatous meningitis.
- •History of significant hemoptysis or hemorrhage within 4 weeks prior to first dose of study drug
- •Malabsorption syndrome, nausea and vomiting uncontrolled by medication, or disease significantly affecting gastrointestinal function likely to interfere with the delivery, absorption, or metabolism of TER-2013
- •Prior therapy:
- •[For TER-2013 monotherapy escalation]: AKT inhibitor
- •[For TER-2013 monotherapy expansion]: AKT/PI3K/PTEN pathway inhibitor
- •[For TER-2013 + fulvestrant combination expansion]: AKT/PI3K/PTEN pathway inhibitor, fulvestrant and other SERDs, mTOR inhibitor; some PIK3CA-altered cohorts allow prior PI3K inhibitor.
- •Other protocol-defined Inclusion/Exclusion Criteria apply
Arms & Interventions
Monotherapy Dose Escalation
Experimental
Intervention: TER-2013 (Drug)
Monotherapy Dose Expansion
Experimental
Intervention: TER-2013 (Drug)
Combination Therapy Dose Expansion
Experimental
Dose Expansion of TER-2013 with recommended dose of fulvestrant
Intervention: TER-2013 (Drug)
Combination Therapy Dose Expansion
Experimental
Dose Expansion of TER-2013 with recommended dose of fulvestrant
Intervention: Fulvestrant injection (Drug)
Combination Therapy Dose Escalation
Experimental
Dose Escalation of TER-2013 with recommended dose of fulvestrant
Intervention: Fulvestrant injection (Drug)
Combination Therapy Dose Escalation
Experimental
Dose Escalation of TER-2013 with recommended dose of fulvestrant
Intervention: TER-2013 (Drug)
Outcomes
Primary Outcomes
Objective Response Rate as assessed by RECIST v1.1
Time Frame: Up to 2 years
Number of Patients who Experience Dose-Limiting Toxicity
Time Frame: 28 Days
Number of patients who experience a treatment-related adverse event
Time Frame: Up to 2 years
Duration of Response as assessed by RECIST v1.1
Time Frame: Up to 2 years
Secondary Outcomes
- Maximum concentration (Cmax) of TER-2013(Up to 2 years)
- Time to maximum concentration (Tmax) of TER-2013(Up to 2 years)
- Terminal elimination half-life (T1/2) of TER-2013(Up to 2 years)
- Area under the plasma concentration-time curve for a dosing interval (AUCτ) of TER-2013(Up to 2 years)
- Changes of pharmacodynamic markers of TER-2013 in tissue and/or blood as assessed by pPRAS40(Up to 2 years)
- Changes of pharmacodynamic markers of TER-2013 in tissue and/or blood as assessed by pAKT(Up to 2 years)
Investigators
Study Sites (27)
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